The US Food and Drug Administration has announced the approval of Benlysta (belimumab) to treat patients with systemic lupus erythematosus. It is the first new drug to be approved for this disease since 1955. The developers are GSK and Human Genome Sciences.
An advisory panel of the US Food and Drug Administration has recommended approval of Novartis’s indacaterol as the first once-daily, long-term maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease.
Topotarget A/S of Denmark reported revenue of DKK 129 million (€17.3 million) in 2010, up from DKK 44 million a year earlier, boosted by an upfront payment from its co-development partner for its lead cancer drug, belinostat.
UCB SA of Belgium has completed the placement of €300 million in perpetual subordinated bonds as part of an ongoing effort to restructure its balance sheet. The new bonds will qualify as equity, the company said.
The European Court of Justice (ECJ) has struck down a proposal from member states of the European Union to create a new, unified jurisdiction for the litigation of patent disputes saying the proposal is incompatible with the EU treaties.
Généthon, a not-for profit French biotherapy laboratory, has announced a collaboration with the Wake Forest University School of Medicine in the US to work on the preclinical development of a gene therapy for myotubular myopathy.
The US Patent and Trademark Office has awarded a patent to the privately-owned Symphogen A/S of Denmark for an oncology compound that is based on a mixture of two anti-epidermal growth factor receptor (EGFR) monoclonal antibodies.
Scientists from the Northwestern University Feinberg School of Medicine in the US have reported transforming human embryonic stem cells into a type of neuron that plays a critical role in memory. The findings have been published in Stem Cells.
AstraZeneca Plc and Bristol-Myers Squibb Co have won a label update in Europe and the US for their Type 2 diabetes drug, Onglyza (saxagliptin), for adults with Type 2 diabetes who have moderate or severe renal impairment.
An investigational drug for patients with Type 2 diabetes has failed to show non-inferiority in a clinical trial that compared it with a competitor. The drug, Bydureon, is an extended release formulation of exenatide.